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Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
oral contraceptive
Oral contraceptive plus spironolactone
Oral contraceptive plus metformin
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Oral Contraceptives, Hormonal, Cardiovascular Disease, Endothelium

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 and 35 years
  • diagnosis of PCOS by Rotterdam Consensus

Exclusion Criteria:

  • smoking, alcoholism, drug addiction;
  • current pregnancy;
  • current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives;
  • current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device);
  • antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins;
  • presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia);
  • personal history of arterial or venous thrombosis; chronic or acute inflammatory processes;
  • puerperium of 12 weeks or less

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate

The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.

The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg metformin.

Outcomes

Primary Outcome Measures

To compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on echografic cardiovascular risk markers.

Secondary Outcome Measures

to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on seric cardiovascular risk markers.
to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on hemostatic variables.
to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on metabolic variables.

Full Information

First Posted
February 10, 2009
Last Updated
July 21, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00842140
Brief Title
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Official Title
Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with Spironolactone.
Detailed Description
Polycystic ovary syndrome (PCOS) is associated with comorbidities that may contribute to increased risk of cardiovascular disease (CVD). Oral contraceptives (OC) have been the mainstay of PCOS pharmacological therapy for decades. However, in non-hyperandrogenic women, OC use is associated with higher risk of cardiovascular disease, raising concern about a possible worsening of the unfavorable metabolic and cardiovascular profile of PCOS patients. There is lack of evidence about the impact of PCOS pharmacological therapies on cardiovascular risk markers and the long-term safety of these drugs in PCOS has not been established. The aim of this study is to compare the effect of an OC alone or associated with an anti-androgenic drug (spironolactone) on echografic cardiovascular risk markers, metabolic and hemostatic variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, Oral Contraceptives, Hormonal, Cardiovascular Disease, Endothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate
Arm Title
2
Arm Type
Experimental
Arm Description
The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.
Arm Title
3
Arm Type
Experimental
Arm Description
The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg metformin.
Intervention Type
Drug
Intervention Name(s)
oral contraceptive
Other Intervention Name(s)
Belara
Intervention Description
oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months
Intervention Type
Drug
Intervention Name(s)
Oral contraceptive plus spironolactone
Other Intervention Name(s)
Belara, Spironolactone
Intervention Description
The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.
Intervention Type
Drug
Intervention Name(s)
Oral contraceptive plus metformin
Other Intervention Name(s)
Belara, Metformin
Intervention Description
Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin
Primary Outcome Measure Information:
Title
To compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on echografic cardiovascular risk markers.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on seric cardiovascular risk markers.
Time Frame
12 months
Title
to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on hemostatic variables.
Time Frame
12 months
Title
to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on metabolic variables.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 35 years diagnosis of PCOS by Rotterdam Consensus Exclusion Criteria: smoking, alcoholism, drug addiction; current pregnancy; current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives; current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device); antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins; presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia); personal history of arterial or venous thrombosis; chronic or acute inflammatory processes; puerperium of 12 weeks or less
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui A Ferriani, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcos Felipe S de Sa, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carolina S Vieira, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

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Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

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